Z-1505-2011

Applied Medical's LAP CHOLE KIT 16 GK; Model Number: GK116 The device is used to close a clip in order to...

Name: Z-1505-2011 Applied Medical's LAP CHOLE KIT 16 GK; Model Number: GK116 The device is used to close a clip in order to...
Creator: Applied Medical Resources Corp
Published: 2010-09-10
License: https://open.fda.gov/license/

Applied Medical Resources Corp / initiated 2010-09-10 / Terminated / root cause: manufacturing process

FDA source

Applied Medical Resources Corp began a recall of Applied Medical's LAP CHOLE KIT 16 GK; Model Number: GK116 The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic... on 2010-09-10. The reason FDA records is "Applied Medical is conducting a voluntary recall of specific lot numbers of the Direct Drive Laparoscopic Clip Applier, model number CA090, due to a potential defect in the jaws, possibly resulting in jaw breakage". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1505-2011
Status: Terminated
Initiated: 2010-09-10
Posted: 2011-03-03
Terminated: 2011-03-09
Recalling firm: Applied Medical Resources Corp
Product: Applied Medical's LAP CHOLE KIT 16 GK; Model Number: GK116 The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures.
Product code: GCJ Laparoscope, General & Plastic Surgery
Reason for recall: Applied Medical is conducting a voluntary recall of specific lot numbers of the Direct Drive Laparoscopic Clip Applier, model number CA090, due to a potential defect in the jaws, possibly resulting in jaw breakage.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Applied Medical sent an URGENT: MEDICAL DEVICE RECALL letter dated September 10, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory and complete the attached Voluntary Recall Notification Confirmation Form and fax it to 949-713-8832. Customers were asked to return all affected product. Secondary consignees were notified by Applied Medical on September 16, 2010. For any questions regarding this recall call 949-713-8041.
Quantity in commerce: 2,843 units for all products
Distribution: Worldwide Distribution - USA including AL, AR, AZ, CA, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OR, PA, SC, TN, TX, VT, WA, and WI and the countries of Australia, Europe, Japan, and Kuwait.
Product codes and lots: LOT NUMBER(S): 1121989

Product code GCJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)